Clinical Trial to Evaluate Efficacy and Safety of SID142 in Patients With Chronic Artery Occlusive Disease

• Status: Completed
• Trial end date: 2018-10-15
• Target enrollment: 0
• Participant gender: All

Summary

Rinexin® Tab (Cilostazol 100mg, Ginkgo biloba leaf extract 80mg) has been widely used as an anti-platelet agent for the treatment of PAD. SID142 is a new controlled-release product improved patient's convenience and disadvantage of dosage regimen of previous drug. The aim of this study was to compare the efficacy and safety of SID142 and Rinexin® Tab in patients with PAD

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SK Chemicals Co., Ltd.; SK Chemicals Co.,Ltd.

Criteria

Inclusion Criteria:

1. Male or Female outpatients over 20years of age

2. patients confirmed to have PAD

• ABI ≤0.9

• Occlusion rate>50%

3. LE PAD with Fontaine stage II/III

4. LE pain VAS≥40mm at screening

Exclusion Criteria:

1. Patients who underwent vascular surgery or endovascular procedure for PAD within 1month prior to study. Patients who need vascular surgery or endovascular procedure for PAD during this study also should be excluded.

2. Patients with peripheral neuropathy.

3. Patients with ischemic heart diseases or underwent percutaneous transluminal coronary angioplasty or coronary artery bypass graft within 6 months prior to study.

4. Patients who has diagnosed cerebrovascular diseases within 6 months prior to study.

5. Patients with hemorrhage or predisposition to hemorrhage at screening visit.

6. Uncontrolled hypertension defined as ≥ 180 mmHg of systolic blood pressure or ≥ 110 mmHg of diastolic blood pressure